FDA 510(k) Applications for Medical Device Product Code "NWA"
(Prosthesis, Tracheal, Preformed/Molded)

FDA 510(k) Number Applicant Device Name Decision Date
K182743 New Cos Inc. Patient-Specific Airway Stent 10/23/2019
K213969 New COS Inc. DBA VisionAir Solutions VisionAir Patient-Specific Airway Stent 10/07/2022
K971509 Novatech S.A. ENDOXANE 08/21/1997
K243126 Novatech SA TRACHEOBRONXANEÖ DUMON« 10/29/2024


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